(56 days)
The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field.
They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.
The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems are part of the Falcon product family of non-invasive peripheral vascular diagnostic systems. The Falcon/Pro is a complete peripheral vascular system that supports 10 independent pressure channels, 5 PPG sensors, 3 Doppler frequencies, and a temperature sensor. The Falcon/Quad and the Falcon/ABI+ systems are merely sub-assemblies of the Falcon/Pro system. Both support only 4 pressure channels, 4 PPG sensors and a temperature sensor. The Falcon/Quad also includes support for the 3 Doppler frequencies, while the Falcon/ABI+ does not support any Doppler features.
The Falcon/Pro and its' sub-assemblies Falcon/Quad and Falcon/ABI+ share the same hardware and software. While the main printed circuit board (PCB) is identical, the pneumatic components such as pumps, valves, sensors and check valves are assembled in the Falcon/Quad and Falcon/ABI+ to support only 4 pressure channels. In addition, one PPG sensor is omitted from the assembly of these systems. Furthermore, the Doppler board with its' PCB mount probe connectors is not assembled in the Falcon/ABI+ system. The same metal enclosure and connectors are used for the Falcon/Pro. Falcon/Quad, and Falcon/ABI+. The only difference lies in the front panel which is adapted according to the number of PPG sensors and Doppler probes.
The software level of concern for the Falcon products is determined as Moderate. The software of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems is practically identical. The only software differences are as follows: the Falcon/Pro supports 10 pressure cuffs (tubing marked in red, blue, green, yellow, orange, and white with lines in red. blue, green, yellow, and orange), while the sub-assemblies support only 4 pressure cuffs (tubing marked in red, blue, green, yellow); the Falcon/Pro supports 5 color coded PPG sensors (red, blue, green, vellow and black) while the sub-assemblies support only 4 such sensors (red, blue, green, yellow); the default examination protocols are adapted according to the supported sensors and probes; the maximal protocol group allowed with the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features.
All other software features are identical for the Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. Some of the main features include patient details and patient database management; Dicom connectivity; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols: measurement site configuration: export in various formats: import of VSX files; backup features; restoring backup data: online help options: and review stations. All of the standard signal control options and signal display options. as well as measurement calculations, are identical for all 3 systems (excluding Doppler related options for the Falcon/ABI+ system).
The quantitative measurements are the same for Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. The main measurement of the 3 systems is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure.
Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure.
The standard main Doppler parameters that are calculated (not for the Falcon/ABI+ system), include: Mean, representing the time-average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak, representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; PI, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / mean velocity; RI. representing the Pourcelot Resistance Index. calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / peak systolic velocity; S/D. representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute.
Additional parameters that are displayed are related to the specialty tests. During stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous reflux testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre-dorsiflexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation.
The Falcon complies with Class B EMC requirements. Therefore, the Falcon is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
The provided text describes the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems, which are non-invasive peripheral vascular diagnostic systems. However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with statistical measures of performance like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
The document indicates that the devices have undergone "extensive safety, performance testing, and validation" and that "various performance testing" was conducted to ensure they meet their functional specifications. It also mentions compliance with several international safety and electrical standards (EN 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971).
Since explicit acceptance criteria and corresponding performance data are not provided, the following table and subsequent sections highlight what is mentioned and what is missing.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Functional Specifications Compliance | "devices meet all of their functional specifications" | Broad statement without specific metrics or evidence. |
| Safety Standards (EN 60601-1, IEC 60601-2-37, ISO 14971) | "certified by an approved laboratory" to comply with standards | Implies regulatory compliance rather than specific performance metrics for the diagnostic output. |
| EMC Standards (IEC 60601-1-2) | "certified by an approved laboratory" to comply with standards; "complies with Class B EMC requirements" | Confirms electromagnetic compatibility. |
| Software Life Cycle (IEC 62304) | "certified by an approved laboratory" to comply | Confirms software development process adherence. |
| Specific Diagnostic Performance Metrics (e.g., accuracy, sensitivity, specificity, agreement with a gold standard for ABI measurements, Doppler velocity, VRT, MVO/SVC ratio) | NOT PROVIDED IN THE SUBMISSION | This is the key missing information for clinical acceptance criteria. |
Detailed Breakdown of Missing Information as Per Request:
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A table of acceptance criteria and the reported device performance:
- As shown above, the document largely refers to compliance with safety and functional specifications broadly. There are no explicit, quantifiable acceptance criteria related to diagnostic performance (e.g., accuracy thresholds for ABI, Doppler velocity measurements) and no reported device performance data against such criteria. The submission states that "the devices meet all of their functional specifications," but these specifications are not detailed or quantified in terms of diagnostic output validity or reliability.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The submission does not describe any specific clinical test set, its size, or its provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Since no specific test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth. The document mentions that it is the "total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training" for segmental blood pressure and other parameters, indicating the device relies on expert interpretation during use.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No specific test set for diagnostic performance is detailed in this submission.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. The device described is a non-invasive peripheral vascular diagnostic system, not an AI-assisted diagnostic tool for human readers in the typical sense of imaging review. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description. The submission focuses on substantial equivalence based on device features and general function to predicate devices, not on a human-AI interaction study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The Falcon devices are diagnostic instruments that capture physiological signals (pressure, PPG, Doppler) and perform calculations based on these signals. While the software automatically places cursors for certain measurements, the submission explicitly states that "it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training." This indicates intended human-in-the-loop operation, and no mention of a standalone algorithm-only performance study is made.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No specific ground truth methodology is described in relation to a study proving diagnostic accuracy. The device produces quantitative measurements (segmental systolic blood pressures, ABI, Doppler parameters, VRT, MVO/SVC ratio) that are then interpreted by medical staff. The document focuses on the correct functioning and calculation capabilities of the device itself, not on its diagnostic accuracy against a clinical gold standard.
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The sample size for the training set:
- Not applicable/Not provided. The device does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It's a measurement and calculation device for physiological signals.
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How the ground truth for the training set was established:
- Not applicable/Not provided. As above, there is no mention of a training set or its associated ground truth establishment.
Summary of the Document's Focus:
This 510(k) submission primarily emphasizes:
- Device Description: Detailing the hardware and software components and functionality of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems.
- Substantial Equivalence: Comparing the new devices to legally marketed predicate devices (Vasoguard and Multilab Series II) based on features, intended use, performance capabilities (e.g., number of pressure channels, PPG sensors, Doppler frequencies, specialty tests), and compliance with general safety and performance standards.
- Safety and Standards Compliance: Stating that the devices meet various electrical and medical device standards (EN, IEC, ISO).
- User Responsibility: Highlighting that medical staff are ultimately responsible for interpreting the data and adjusting cursors for measurements.
The submission does not include data from clinical trials or performance studies that would typically provide specific acceptance criteria and detailed quantitative diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) against a defined ground truth for conditions like peripheral vascular pathology. The approval is based on demonstrating substantial equivalence to existing devices already on the market rather than on new clinical performance data.
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).